A Study of Sterile Saline Infusion in Healthy Volunteers

A Phase 0, Single-Center Study to Evaluate the Safety and Tolerability of Injecting Sterile Saline Subcutaneously Into the Abdomen and Thigh of Healthy Volunteers Using Varying Volumes and Rates of Infusion

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06194578

Enrollment

Registered

2024-01-08

Start date

2024-01-12

Completion date

2024-04-23

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.

Interventions

OTHERSterile Saline

Sterile saline will be administered subcutaneously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Body Mass Index greater than (\>)18 and less than (\<) 36 * Able to understand the English language * Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention

Exclusion criteria

* Age \< 18 years and \> 60 years * BMI \< 18 or \> 36 * Unable to understand the English language * Currently pregnant or lactating * History of skin sensitivity or allergy to steel needle or adhesive tape * History of abnormal blood coagulation or bleeding * History of abnormal immune function or frequent skin infections * Active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease * Has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame	Description
Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score	Up to 10 minutes after completion of the saline infusion	Participant's pain intensity during or after the saline infusion as assessed by VAS score will be reported. VAS is a self-reported pain rating scale ranging 0=no pain to 100=worst possible pain.
Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)	Up to 10 minutes after completion of the saline solution	Participant's pain intensity during or after the saline infusion as assessed by VPS will be reported. VPS will be graded by participants as none, mild, moderate, and severe.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026